Regulatory Dossiers
Preparation of complete regulatory dossiers in CTD, eCTD, and local formats. We ensure all modules meet regional requirements and quality standards.
Regulatory Medical Writing
High-quality regulatory documentation for successful submissions. Expert medical writers delivering clear, compliant, and scientifically accurate regulatory documents.
Service 05 / 0705What we deliver
Professional Medical Writing Services
Comprehensive documentation support for regulatory success
Clinical Study Reports
Comprehensive clinical study reports following ICH E3 guidelines. We transform complex clinical data into clear, regulatory-compliant narratives.
Investigator Brochures
Development of comprehensive investigator brochures for clinical trials. We compile and present safety and efficacy data in accessible formats.
Clinical Protocols
Design and writing of robust clinical trial protocols. We ensure scientific rigor while maintaining clarity and regulatory compliance.
Summary Documents
Expert preparation of clinical and non-clinical summaries, overviews, and expert reports for regulatory submissions.
Document Review & Editing
Quality review and editing of existing regulatory documents. We ensure consistency, accuracy, and compliance with current guidelines.
Why ECP
Local expertise. Global standards.
A consortium of professionals with over 15 years of experience and in-depth knowledge of African Medicines Regulatory Authorities and the standards they apply.
- Nairobi-based specialists with regional reach across 25+ countries
- A multidisciplinary team covering regulatory, clinical, safety and quality
- A track record with leading pharmaceutical organisations
How we work
Our Writing Process
Systematic approach to regulatory documentation
1
Project Planning
Define scope, timelines, and deliverables
2
Data Collection
Gather and review source documents
3
Drafting
Prepare initial document drafts
4
Review & Revision
Internal QC and client review cycles
5
Finalization
Deliver publication-ready documents
Continue exploring
Other ECP services.
06
Labeling & Artwork
End-to-end labeling services and comprehensive solutions for artwork management.
07Pharmacovigilance
Drug safety and efficacy assured through comprehensive pharmacovigilance services.
01Strategic Regulatory Intelligence
Stay ahead of evolving regulatory environments in African markets with strategic intelligence.
Begin
Elevate Your Regulatory Documentation
Partner with ECP for expert medical writing services across Africa. Tell us about your product and target markets and we will respond with a clear next step.